Registration Dossier
Registration Dossier
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EC number: 701-361-3 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
Carcinogenicity, mice, dermal, 94 weeks (2 times/week/25µL 10% v/v aceton): not carcinogenic, (Cytec, Kettering Laboratory, 1987, outdated protocol)
Key value for chemical safety assessment
Justification for classification or non-classification
Oxirane, methyl-, polymer with oxirane, ether with 2 -ethyl-2 -(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate did not induce gene mutations in bacteria or mammalian cells. Although a chromosome damaging potential in the absence of metabolic activation was observed in an in vitro micronucleus assay, no evidence of a mutagenic effect was seen for structural analogues when tested in whole animal clastogenicity/aneuploidy studies. A less reliable carcinogenicity study with the read across substancePropylidynetrimethanol, ethoxylated, esters with acrylic acid, caused no concern for a carcinogenic potential. Taken together, there is no reason to assume, that the test substance is carcinogenic. Thus, it is not classified according to EU criteria (CLP/EU-GHS).
Additional information
No studies exist for Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate, but for the structurally similar substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid (CAS28961 -43 -5), a lifetime study was conducted to assess its carcinogenic potential. Although the study was performed according to an outdated protocol and is thus not reliable without restriction, though well-documented, it supports the conclusion drawn from the genetic toxicity studies, that there is no concern for a carcinogenic potential.
Male C3H/HeJ mice (50/dose) were topically treated with 25 µL of 10 % v/v in acetone, twice weekly for 94 weeks. The dose and concentration of each material were selected after completion of a pilot study. Control animals received no treatment or 50 µL of acetone twice weekly. The positive control group received 50 µL of 0.025 % benzo(a)pyrene (BaP) in acetone twice weekly. No significant difference in body weight gains was observed between the test and control groups. Slight to moderate hyperkeratosis (in 12 mice); no treatment-related skin neoplasms (one lesion, diagnosed grossly as a skin tumor, was actually an abscess in the dermis; skin tumor in another mouse was a metastasis from lymphocytic lymphoma) were observed at the application sites. Examination of internal organs revealed no treatment related lesions.
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